ConstipationPhase 3NCT00576810

Sodium Picosulphate vs. Placebo in Functional Constipation

A Phase 3 study testing sodium picosulphate in people with Constipation, run by Boehringer Ingelheim at 43 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective ot the study is to compare the efficacy and safety of 4 weeks treatment with sodium picosulphate drops 10mg to placebo in patients with functional constipation. In addition the effect of treatment on quality of life and general health status will be evaluated Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Constipation
What is being tested?: sodium picosulphate
How many people: 367 participants
Where: 43 sitesGermany
Study dates: Oct 2007to Jan 2009
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients, aged 18 and above
Suffering from functional constipation, according to their medical history, as defined by the Rome III diagnostic criteria Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
Must include 2 or more of the following:
straining during at least 25% of the defecations
lumpy or hard stools in at least 25% of the defecations
sensation of incomplete evacuation for at least 25% of the defecations

Show all 14Show fewer

sensation of anorectal obstruction/blockade for at least 25% of the defecations
manual manoeuvres to facilitate at least 25% of the defecations (e.g. digital evacuation, support of the pelvic floor)
fewer than 3 defecations per week
Loose stools are rarely present without the use of laxatives
There are insufficient criteria for irritable bowel syndrome (IBS) (i.e. recurrent abdominal pain or discomfort is not the predominant symptom associated with defecation or a change in bowel habit, and with features of disordered defecation)
Able and willing to complete a daily e-diary
Able and willing to use the trial rescue medication (i.e. 10 mg bisacodyl suppositories)
Signed and dated written informed consent prior to enrolment into the study in accordance with GCP and local legislation

Who cannot join

Eating disorders such as anorexia nervosa and bulimia, as a cause of excessive use of laxatives
Patients whose constipation is caused by primary organic disease of the colon or pelvic floor
Patients with metabolic disorders, neurological disorders, severe or psychiatric disorders, or any other significant disease or intercurrent illness (e.g. abdominal/gastrointestinal surgery) that, in the Investigators opinion, would interfere with participation in the trial
Patients with restricted mobility (e.g. wheelchair bound, or bed-ridden) that, in the Investigators opinion, would interfere with participation in the trial
Patients with a known hypersensitivity to sodium picosulphate, bisacodyl or any other ingredient in the study medication (sodium picosulphate and matching placebo drops, bisacodyl suppositories)
Patients with ileus, intestinal obstruction, acute surgical abdominal conditions (such as acute appendicitis and acute inflammatory bowel diseases), or severe dehydration

Show all 15Show fewer

Patients with anal fissures or ulcerative proctitis with mucosal damage
Patients with known clinically significant abnormal electrolyte values
Patients whose concomitant therapy includes an opioid medication (e.g. morphine, codeine)
Constipation which, in the Investigators opinion, is caused by medication (e.g. anticholinergics)
Patients who are not willing to discontinue the use of prohibited concomitant therapy (see Section 4.2.2)
Pre-menopausal women (last menstruation £ 1 year prior to signing informed consent) who:are nursing (breast-feeding) or who are pregnant OR who are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study.
Participating in another trial with an investigational product with 1 month of enrolment into this study
Drug or alcohol abuse
Concomitant use of antibiotics

Trial locations and contacts

43 sites in 1 country.

City, postcode or hospital

43 sites in 1 country

Germany43 sites

1062.7.4926 Boehringer Ingelheim Investigational Site
Amberg
1062.7.4918 Boehringer Ingelheim Investigational Site
Bad Essen
1062.7.4946 Boehringer Ingelheim Investigational Site
Bergkamen
1062.7.4904 Boehringer Ingelheim Investigational Site
Berlin
1062.7.4929 Boehringer Ingelheim Investigational Site
Berlin
1062.7.4902 Boehringer Ingelheim Investigational Site
Blankenhain
1062.7.4927 Boehringer Ingelheim Investigational Site
Dortmund
1062.7.4954 Boehringer Ingelheim Investigational Site
Dortmund
1062.7.4949 Boehringer Ingelheim Investigational Site
Dresden
1062.7.4950 Boehringer Ingelheim Investigational Site
Einbeck
1062.7.4909 Boehringer Ingelheim Investigational Site
Freising
1062.7.4923 Boehringer Ingelheim Investigational Site
Fürth
1062.7.4912 Boehringer Ingelheim Investigational Site
Hagen
1062.7.4953 Boehringer Ingelheim Investigational Site
Hamburg
1062.7.4910 Boehringer Ingelheim Investigational Site
Hanover
1062.7.4920 Boehringer Ingelheim Investigational Site
Herne
1062.7.4944 Boehringer Ingelheim Investigational Site
Ingelheim
1062.7.4936 Boehringer Ingelheim Investigational Site
Jena
1062.7.4925 Boehringer Ingelheim Investigational Site
Leipzig
1062.7.4931 Boehringer Ingelheim Investigational Site
Leipzig
1062.7.4907 Boehringer Ingelheim Investigational Site
Leverkusen
1062.7.4922 Boehringer Ingelheim Investigational Site
Lüdenscheid
1062.7.4930 Boehringer Ingelheim Investigational Site
Lüdenscheid
1062.7.4942 Boehringer Ingelheim Investigational Site
Ludwigsburg
1062.7.4906 Boehringer Ingelheim Investigational Site
Ludwigsfelde
1062.7.4941 Boehringer Ingelheim Investigational Site
Ludwigshafen
1062.7.4911 Boehringer Ingelheim Investigational Site
Lützen
1062.7.4916 Boehringer Ingelheim Investigational Site
Marburg
1062.7.4948 Boehringer Ingelheim Investigational Site
Marl
1062.7.4921 Boehringer Ingelheim Investigational Site
Oelde
1062.7.4935 Boehringer Ingelheim Investigational Site
Offenbach
1062.7.4903 Boehringer Ingelheim Investigational Site
Potsdam
1062.7.4937 Boehringer Ingelheim Investigational Site
Recklinghausen
1062.7.4956 Boehringer Ingelheim Investigational Site
Reichenbach
1062.7.4905 Boehringer Ingelheim Investigational Site
Saarbrücken
1062.7.4933 Boehringer Ingelheim Investigational Site
Salzkotten
1062.7.4943 Boehringer Ingelheim Investigational Site
Stendal
1062.7.4955 Boehringer Ingelheim Investigational Site
Stuhr
1062.7.4957 Boehringer Ingelheim Investigational Site
Thedinghausen
1062.7.4913 Boehringer Ingelheim Investigational Site
Wallerfing
1062.7.4924 Boehringer Ingelheim Investigational Site
Wardenburg
1062.7.4914 Boehringer Ingelheim Investigational Site
Wiesbaden
1062.7.4901 Boehringer Ingelheim Investigational Site
Winsen

Other trials in Germany

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks Treatment With Sodium Picosulfate [Dulcolax®, Laxoberal®]Drops 10 mg Administered Orally, Once Daily, in Patients With Functional Constipation

Conditions: Constipation
Being tested: sodium picosulphate
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sodium picosulphateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary endpoint in this trial is the mean number of complete spontaneous bowel movements (CSBMs) per week, during the 4 week treatment phase of the trial.
Measured: 4 weeks

Secondary outcomes (18)

Number of CSBMs per week, at each weekly time point during the treatment phase of the trial (i.e. at each of weeks 1, 2, 3 and 4)
Measured: 4 weeks
Number of spontaneous bowel movements (SBMs) per week after the first intake of the study medication
Measured: 4 weeks
Time to first SBM following the first intake of the study medication
Measured: 4 weeks
Number of patients with an increase of ≥ 1 CSBM per week compared with the last 7 days of the baseline period
Measured: 4 weeks
Number of patients with ≥ 1 CSBM a day
Measured: 4 weeks
Number of patients with ≥ 3 CSBMs per week
Measured: 4 weeks
Number of premature withdrawals
Measured: 4 weeks
Number of patients who have used rescue medication
Measured: 4 weeks
Change from baseline in mean score per week for constipation symptoms
Measured: 4 weeks
Change from baseline in the patients' score per week for overall satisfaction with bowel habits and bothersomeness of constipation symptoms
Measured: 4 weeks
Final global assessment of efficacy by the investigator (good, satisfactory, not satisfactory, bad)
Measured: 4 weeks
Final global assessment of efficacy by the patient (good, satisfactory, not satisfactory, bad)
Measured: 4 weeks
Quality of Life (SF-36v2and PAC-QOL)
Measured: 4 weeks
Blood pressure
Measured: 4 weeks
Number of participants with abnormal serum electrolyte laboratory parameters
Measured: 4 weeks
Number of participants with abnormal serum chemistry laboratory parameters
Measured: 4 weeks
Final global assessment of tolerability by the investigator (good, satisfactory, not satisfactory, bad)
Measured: 4 weeks
Final global assessment of tolerability by the patient (good, satisfactory, not satisfactory, bad)
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Jan 2009

First posted19 Dec 2007 (estimated)
Study startOct 2007
Primary completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ConstipationStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Intervention model: Parallel groups
Enrolment: 367 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00576810
Sponsor's protocol ID: 1062.7
Other IDs: EURDRACT2007-002087-10
Status last verified: Apr 2014
First submitted: 29 Oct 2007
Last updated: 16 May 2014
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation

All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks Treatment With Sodium Picosulfate [Dulcolax®, Laxoberal®]Drops 10 mg Administered Orally, Once Daily, in Patients With Functional Constipation
ClinicalTrials.gov ID: NCT00576810
Acronym / sponsor ID: 1062.7
Conditions: Constipation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 367 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Jan 2009 (actual)
First posted: 19 Dec 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Intervention model: Parallel groups

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Male and female patients, aged 18 and above
Suffering from functional constipation, according to their medical history, as defined by the Rome III diagnostic criteria Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
Able and willing to complete a daily e-diary
Able and willing to use the trial rescue medication (i.e. 10 mg bisacodyl suppositories)
Signed and dated written informed consent prior to enrolment into the study in accordance with GCP and local legislation

Key exclusion criteria (15 listed)

Eating disorders such as anorexia nervosa and bulimia, as a cause of excessive use of laxatives
Patients whose constipation is caused by primary organic disease of the colon or pelvic floor
Patients with metabolic disorders, neurological disorders, severe or psychiatric disorders, or any other significant disease or intercurrent illness (e.g. abdominal/gastrointestinal surgery) that, in the Investigators opinion, would interfere with participation in the trial
Patients with restricted mobility (e.g. wheelchair bound, or bed-ridden) that, in the Investigators opinion, would interfere with participation in the trial
Patients with a known hypersensitivity to sodium picosulphate, bisacodyl or any other ingredient in the study medication (sodium picosulphate and matching placebo drops, bisacodyl suppositories)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
sodium picosulphate	Drug	–

Primary outcome

The primary endpoint in this trial is the mean number of complete spontaneous bowel movements (CSBMs) per week, during the 4 week treatment phase of the trial.
Time frame: 4 weeks

18 secondary outcomes

Number of CSBMs per week, at each weekly time point during the treatment phase of the trial (i.e. at each of weeks 1, 2, 3 and 4)
Time frame: 4 weeks
Number of spontaneous bowel movements (SBMs) per week after the first intake of the study medication
Time frame: 4 weeks
Time to first SBM following the first intake of the study medication
Time frame: 4 weeks
Number of patients with an increase of ≥ 1 CSBM per week compared with the last 7 days of the baseline period
Time frame: 4 weeks
Number of patients with ≥ 1 CSBM a day
Time frame: 4 weeks
Number of patients with ≥ 3 CSBMs per week
Time frame: 4 weeks
Number of premature withdrawals
Time frame: 4 weeks
Number of patients who have used rescue medication
Time frame: 4 weeks
Change from baseline in mean score per week for constipation symptoms
Time frame: 4 weeks
Change from baseline in the patients' score per week for overall satisfaction with bowel habits and bothersomeness of constipation symptoms
Time frame: 4 weeks
Final global assessment of efficacy by the investigator (good, satisfactory, not satisfactory, bad)
Time frame: 4 weeks
Final global assessment of efficacy by the patient (good, satisfactory, not satisfactory, bad)
Time frame: 4 weeks
Quality of Life (SF-36v2and PAC-QOL)
Time frame: 4 weeks
Blood pressure
Time frame: 4 weeks
Number of participants with abnormal serum electrolyte laboratory parameters
Time frame: 4 weeks
Number of participants with abnormal serum chemistry laboratory parameters
Time frame: 4 weeks
Final global assessment of tolerability by the investigator (good, satisfactory, not satisfactory, bad)
Time frame: 4 weeks
Final global assessment of tolerability by the patient (good, satisfactory, not satisfactory, bad)
Time frame: 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
Related InfoLink provided by the sponsor.

Related trials for Constipation

Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

43 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sodium picosulphate in people with Constipation, run by Boehringer Ingelheim at 43 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint in this trial is the mean number of complete spontaneous bowel movements (CSBMs) per week, during the 4 week treatment phase of the trial. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00576810.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.